Study to Characterize the PK and Local Extent and Duration of Exposure From FX006 in Patients With OA of the Knee
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|ClinicalTrials.gov Identifier: NCT02637323|
Recruitment Status : Completed
First Posted : December 22, 2015
Results First Posted : January 12, 2018
Last Update Posted : January 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis of the Knee||Drug: FX006 32 mg Drug: TCA IR 40||Phase 2|
This study employed an open-label, single administration design and was conducted in male and female patients ≥40 years of age with OA of the knee.
Patients were enrolled sequentially with at least 10 patients per cohort as follows:
Cohort A: FX006 32 mg, Final Visit at Week 20 Cohort B: FX006 32 mg, Final Visit at Week 16 Cohort C: FX006 32 mg, Final Visit at Week 12 Cohort D: FX006 32 mg, Final Visit at Week 6 Cohort E: FX006 32 mg, Final Visit at Week 1 Cohort F: TCA IR 40 mg, Final Visit Week 6
Each patient was screened to confirm eligibility and assigned to a cohort on Day 1/baseline. Each patient was evaluated for safety during his/her participation in the study at 6, 12, 16, or 20 weeks following a single IA injection depending on the assigned Cohort, and plasma and synovial fluid was collected for drug concentration measurements.
Safety and tolerability was assessed by physical examinations, index knee examinations, vital signs, clinical laboratory evaluations, and adverse events (AEs).
No efficacy assessments were employed in this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||81 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label, Single Administration Study to Characterize the Systemic Pharmacokinetics and Local Extent and Duration of Exposure of Triamcinolone Acetonide From FX006 in Patients With Osteoarthritis of the Knee|
|Study Start Date :||November 2015|
|Actual Primary Completion Date :||September 2016|
|Actual Study Completion Date :||September 2016|
Experimental: FX006 32 mg
Single 5 mL intra-articular (IA) injection Extended-release formulation
Drug: FX006 32 mg
Single 5 mL IA injection
Other Name: Zilretta
Active Comparator: TCA IR 40 mg
Commercially available triamcinolone acetonide, single 1 mL intra-articular (IA) injection Immediate-release formulation
Drug: TCA IR 40
Single 1 mL IA injection
- Synovial Fluid Drug Concentrations (pg/mL) by Time Point Pooled Across FX006 Cohorts and TCA IR in Synovial Fluid [ Time Frame: Up to 20 Weeks ]All baseline (pre-treatment) values and all post-baseline values recorded as below LLOQ (<50 pg/mL) were set to zero. Geometric mean summary statistics were computed on adjusted concentration values. One (1) was added to each concentration value observed. BLQ values for the computation of geometric mean are included in the summary with a value of 1 (0+1).
- Plasma Drug Concentrations (pg/mL) by Time Pooled Across FX006 Cohorts and TCA IR 40 mg Cohort [ Time Frame: Up to 20 Weeks ]All baseline (pre-treatment) values and all post-baseline values that are recorded as below LLOQ were set to zero for analysis and were included in the descriptive mean calculations. Values below LLOQ were not included in geometric mean calculations.
- Plasma Pharmacokinetic Parameters for FX006 and TCA IR [ Time Frame: Up to 20 Weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02637323
|United States, California|
|Canoga Park, California, United States, 91303|
|San Diego, California, United States, 92103|
|United States, Florida|
|Hialeah, Florida, United States, 33012|
|United States, Pennsylvania|
|Duncansville, Pennsylvania, United States, 16635|
|Study Director:||Neil Bodick, MD||Flexion Therapeutics|